AstraZeneca Stock Price, News & Analysis

AstraZeneca will present significant clinical trial data at the 2025 ASCO Annual Meeting (May 30-June 3), marking its seventh consecutive year with plenary presentations. The company will showcase over 80 abstracts featuring 20 medicines, including two plenary presentations. Key highlights include the SERENA-6 Phase III trial of camizestrant for HR-positive breast cancer, MATTERHORN Phase III trial of IMFINZI for gastric cancer, and DESTINY-Breast09 Phase III trial of ENHERTU for HER2-positive metastatic breast cancer. The SERENA-6 trial is notably the first positive Phase III trial for a next-generation oral SERD in first-line setting, while DESTINY-Breast09 is the first trial in over a decade showing superiority over first-line standard care in HER2-positive metastatic patients.

AstraZeneca's AIRSUPRA demonstrated exceptional results in the Phase IIIb BATURA trial for mild asthma treatment. The study showed a 47% reduction in severe exacerbation risk compared to albuterol alone (5.1% vs 9.1%, p<0.001). The trial was stopped early due to overwhelming efficacy. Key findings include a 63% reduction in systemic corticosteroid exposure and consistent safety profile with albuterol. AIRSUPRA is the first FDA-approved anti-inflammatory rescue medication for as-needed treatment in asthma patients 18 and older. The results, published in the New England Journal of Medicine and presented at ATS 2025, support AIRSUPRA as a potential new standard of care, particularly significant for mild asthma patients who represent 50-70% of cases and account for up to 30% of asthma-related exacerbations and deaths.

AstraZeneca (AZN) will present over 75 abstracts, including 8 late-breakers, at the American Thoracic Society (ATS) International Conference from May 16-21, 2025. The presentations focus on their respiratory portfolio targeting asthma, COPD, and other inflammatory diseases. Key highlights include:

- AIRSUPRA data showing potential as preferred rescue treatment across all asthma severities

- BREZTRI studies demonstrating impact on cardiopulmonary outcomes in COPD patients

- FASENRA research in EGPA treatment and eosinophilic inflammation

- TEZSPIRE data on severe asthma and chronic rhinosinusitis

- Early-stage pipeline developments including AI/machine learning applications in respiratory disease research

The company aims to transform respiratory care, addressing COPD as the third leading cause of death worldwide and targeting unmet needs in asthma treatment.

AstraZeneca's IMFINZI® (durvalumab) demonstrated significant success in a Phase III POTOMAC trial for treating high-risk non-muscle-invasive bladder cancer (NMIBC). The study showed that one year of IMFINZI treatment combined with standard BCG therapy significantly improved disease-free survival (DFS) compared to BCG therapy alone. This is particularly significant as over 70% of bladder cancer patients are diagnosed with NMIBC, and about half are classified as high-risk. Currently, 80% of patients experience disease recurrence, with almost half potentially requiring bladder removal surgery. The safety profile was consistent with known data, and the addition of IMFINZI did not compromise BCG therapy completion. However, a second experimental arm testing IMFINZI plus BCG induction-only therapy did not meet the DFS endpoint.

AstraZeneca and Daiichi Sankyo announced positive Phase III trial results for ENHERTU in treating high-risk HER2-positive early-stage breast cancer. The DESTINY-Breast11 trial demonstrated that ENHERTU followed by THP showed a statistically significant improvement in pathologic complete response (pCR) rate compared to standard treatment. The trial also revealed an improved safety profile versus standard of care, with early positive trends in event-free survival. This marks the first Phase III trial showing ENHERTU's benefit in early breast cancer, potentially challenging current treatment standards. The safety profile was consistent with known data, and interstitial lung disease rates were similar across treatment arms. Notably, approximately one in three patients with early-stage breast cancer are considered high risk, and nearly half of patients receiving current neoadjuvant treatment do not achieve pCR.

AstraZeneca and Daiichi Sankyo announced positive Phase 3 trial results for ENHERTU® in treating high-risk HER2-positive early-stage breast cancer. The DESTINY-Breast11 trial demonstrated that ENHERTU followed by THP showed a statistically significant improvement in pathologic complete response (pCR) compared to standard treatment when used before surgery. The study revealed an improved safety profile versus standard care, with similar rates of interstitial lung disease across treatment arms. Early event-free survival data showed a positive trend favoring ENHERTU. This marks the first Phase 3 trial demonstrating ENHERTU's benefit in early breast cancer, potentially challenging current treatment standards. Approximately one-third of early-stage breast cancer patients are considered high-risk, with current treatments achieving pCR in only about half of patients.

AstraZeneca's BREZTRI AEROSPHERE achieved significant success in Phase III KALOS and LOGOS trials for uncontrolled asthma treatment. The trials demonstrated statistically significant and clinically meaningful improvement in lung function compared to dual-combination ICS/LABA medicines. The study included approximately 4,400 randomized patients, evaluating BREZTRI's 320/28.8/9.6μg dose. This development is particularly significant as 262 million people worldwide are affected by asthma, with nearly half of those on dual therapy remaining uncontrolled. BREZTRI, already approved for COPD treatment in over 80 countries, showed no new safety or tolerability concerns during these trials. The positive results position BREZTRI as a potential new treatment option for asthma patients who remain uncontrolled with current dual maintenance therapy.

AstraZeneca reported strong Q1 2025 financial results with total revenue up 10% to $13,588 million. The growth was driven by double-digit performance in Oncology and BioPharmaceuticals across all major regions. Core EPS increased 21% to $2.49, while reported EPS rose 34% to $1.88.

The quarter saw five positive Phase III readouts and 13 approvals in major regions. Key clinical successes included DESTINY-Breast09 for Enhertu, SERENA-6 for camizestrant, and MATTERHORN for Imfinzi. The company maintains its 2025 guidance, expecting high single-digit revenue growth and low double-digit Core EPS growth.

Strategic developments include the acquisition of EsoBiotec for up to $1 billion, FibroGen China purchase for $160 million, and establishment of a new R&D center in Beijing. The company is progressing toward its 2030 ambition of $80 billion in Total Revenue, supported by eleven US production sites and planned investments in manufacturing and R&D.

Puma Biotechnology presented clinical data for neratinib at the AACR Annual Meeting 2025 in Chicago. The Phase I trial (NCI 10495) evaluated the combination of neratinib with trastuzumab deruxtecan in patients with HER2-altered solid tumors.

Key findings from the 20-patient trial:

• Most common side effects: nausea (75%), diarrhea (75%), fatigue (65%)
• 4 patients achieved partial responses, including cases of gastroesophageal, pancreatic, and ovarian cancers
• Notable results in pancreatic cancer: 3 of 5 patients showed tumor shrinkage

The study established Dose Level 3 as the recommended Phase II dose: trastuzumab deruxtecan at 5.4 mg/kg combined with neratinib starting at 120 mg (week 1), increasing to 160 mg (week 2), and 240 mg (week 3 onward). Part 2 of the study, focusing on pharmacodynamic evaluation in 12 patients, began enrollment in March 2025.